- Getting Started (ilt_a20012):In this 1 hour course, attendees will be review the key items to have in place prior to enrolling the first patient. Learning objectives include: understanding the regulatory binder purpose and set-up; understand the importance of training; and, source document collection and maintenance.
- Informed Consent (ilt_a20013): in this 1 hour course, attendees will learn good clinical practices for conducting the informed consent process; discuss the essential elements of an informed consent document; and review possible issues involved in obtaining an informed consent.
- Overview of Human Subjects Regulations (ilt_a20017): --This 2 hour training will provide an introduction to human subjects research and the differences between Exempt, Expedited, and Full Board reviews and an introduction to human subject research involving vulnerable populations. Instructor: Warren Capell, MD (bio)Director, Colorado Multiple Institutional Review Board, Assistant Professor of Medicine Division of Endocrinology, Metabolism, and Diabetes.
- Clinical Trial Design (ilt_a20018): This is a 1-hour course that provides insight into how and why clinical trials are designed the way they are. Topics include defining the study population, common characteristics, key aims of phases, randomization, blinding, and outcomes analysis. This course is perfect for people who have worked in clinical trials and want to better understand the science behind the method and anyone who is considering designing a clinical trial. Instructor: Jeff Galinkin, MD.
- Submitting to COMIRB (ilt_a20019): In this 2 hour training participants will learn the step by step guide to filling out the COMIRB application and the attachments. Instructor: Warren Capell, MD Director, Colorado Multiple Institutional Review Board.
- Writing Informed Consents (ilt_a20020): This 2 1/2 hour training will go over considerations and regulations for the entire consent process. Participants will also learn how to write consents at reading levels below 8th grade and how to check for missing pieces. Instructor: Yvonne Kellar-Guenther PhD University of Colorado Denver.
- IRB Responsibilities After Initial Approval (ilt_a20021): This 2 hour training will review the reporting responsibilities of the PI once the study has been initially approved by COMIRB. It will include how to submit unanticipated problems, amendments and continuing review requirements. Instructor: Warren Capell, MD Director, Colorado Multiple Institutional Review Board.
- Recruitment and Retention of Study Subjects (ilt_a20022): This 2 hour training will go over the steps involved in recruitment, national studies that have had a high take-up and retention rate, and the regulations surrounding recruitment. Also included will be a section on recruiting protected and special populations. Instructor: Yvonne Kellar-Guenther PhD University of Colorado Denver.
- Clinical Trial Practicum--Study Start-Up ( ilt_a20023): This one-hour course is perfect for coordinators and investigators who want to better understand how to start a clinical trial from the perspective of the Sponsor, the FDA, the IRB and the site. Topics covered include, but are not limited to: how to get selected as a site for a trial; how to develop a recruitment plan; and required regulatory documents to start a trial (includes hands-on 1572 exercise). Learning objectives: understand the activities during the start-up of a clinical trial and practice relevant site activities conducted during start-up of a clinical trial. Instructor: Marilyn Greenwalt.
- Clinical Trial Practicum--Study Maintenance ( ilt_a20024): This one-hour course is perfect for coordinators and investigators who want to better understand the enrollment phase of a clinical trial from the perspective of the Sponsor, the FDA, the IRB and the site. Topics covered include, but are not limited to: informed consent process (including hands-on exercise); implementing protocols (including hands-on exercise); creating and maintaining appropriate documentation. Learning objectives: understand the activities during the enrollment phase of a clinical trial and practice relevant site activities conducted during the enrollment of a clinical trial. Instructor: Marilyn Greenwalt.
- Clinical Trial Practicum--Study Close-out ( ilt_a20025): This one-hour course is perfect for coordinators and investigators who want to better understand the participant follow up and close out phases of a clinical trial from the perspective of the Sponsor, the FDA, the IRB and the site. Topics covered include, but are not limited to: adverse events and serious adverse events (including hands-on exercise); responding to data queries (including hands-on exercise); close-out monitoring visits. Learning objectives: understand the activities during the participant follow up and close out phases of a clinical trial and practice relevant site activities conducted during the participant follow up and close out phases of a clinical trial. Instructor: Marilyn Greenwalt.
- Introduction to Responsible Conduct of Research (ilt_a20027): This 1 hour course provides the student with a practical overview of the rules, regulations, and professional practices that define responsible conduct of research. Instructor: Alison Lakin RN, LLB, LLM, PhD Assistant Vice Chancellor for Regulatory Compliance
- How FDA and COMIRB Interact (ilt_a20028): This 2 hour course will provide students with an overview of both FDA and COMIRB requirements and expectations following initial approval of a clinical trial project. This course will cover continuing reviews, adverse event reporting and protocol amendments. Instructor: Warren Capell, MD Director, Colorado Multiple Institutional Review Board
- Preparing for FDA Audits (ilt_a20029): This 2 hour course will provide the participant with a practical understanding of what to expect before, during and after an FDA audit. The instructor will cover audit preparation for both your trial and your research site, and advice for during and after the audit. A review of common findings and 483 content will be covered.
- Budgeting for Clinical Trials (ilt_a20030): This 1 1/2 hour training will go over the steps needed to create a clinical trial budget template, thinking through what needs to be included, and how to check for overlooked items. Instructor: Jen Maitlen, RN BSN CCRP Education Development Manager University of Colorado Cancer Center and Colorado Clinical Translational Sciences Institute. This course is also offered ONLINE. See below for instructions for accessing the online component.
- UCH Research Billing and Compliance (ilt_a20031): This 2 hour course will cover the UCH billing process as it relates to clinical research. Other topics include Medicare and other insurance billing compliance and law. This is an essential course if your clinical research involves University of Colorado Hospital space and/or patients.
- Human Gene Transfer: Submitting to the Institutional Bio-safety Committee (ilt_a20032): This 30 min course will provide an overview of requirements for submitting to the IBC. In addition, this course will help you to understand what studies require IBC review/approval and why. Instructor: Terry Stinnet, Department of Bio-Safety.
- HIPAA Regulations and Overview (ilt_a20033): This 1 hour course will provide the participant with an overview of HIPAA law, regulations and requirements as it relates to clinical research and human subjects protections. Instructor (rotating): Barbara A. Kakenmaster, RN JD Compliance and Privacy Officer, Office of Regulatory Compliance and Alison Lakin.
- Conflict of Interest (ilt_a20034): This 1 hour course provides the participant with an overview of current regulations--both Federal and local--governing COI and clinical trial conduct. Instructor (rotating): Barbara A. Kakenmaster, RN JD Compliance and Privacy Officer, Office of Regulatory Compliance and Alison Lakin
- Export Control, What is a "Deemed Export" (ilt_a20035): This 1 hour course provides the participant with an overview of current regulations--both Federal and local--governing export control. Instructor: Alison Lakin
- CTO/CTRC Overview (ilt_a20014): In this 1 hour session, attendees will participate in a walking tour of both the in- and out-patient UCH CTO & CTRC. The tour will include the process for scheduling patients, where specific CTO/CTRC patient procedures take place (i.e. blood collection, ECHO and EKG), ideal areas within these clinics for coordinators to utilize computers and phones; and overall process flow in these departments.
- >Vital Signs, Ht/Wt Competency Training (ilt_a20015): In this 1 hour course, attendees will observe the correct methods for obtaining height, weight and vital signs (blood pressure, temperature, pulse and respirations) from adult patients. Attendees will be given multiple opportunities to demonstrate competency with training UCH medical professionals.
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